Rouamba Toussaint, Valea Innocent, Bognini Joel D, Kpoda Herve, Mens Petra F, Gomes Melba F, Tinto Halidou, Kirakoya-Samadoulougou Fati
Centre de Recherche en Epidémiologie, Biostatistique et Recherche Clinique, Ecole de Santé Publique, Université libre de Bruxelles, Brussels, Belgium.
Centre National de la Recherche Scientifique et de la Technologie, Institut de Recherche en Science de la Santé, Unité de Recherche Clinique de Nanoro, Nanoro, Burkina Faso.
Drugs Real World Outcomes. 2018 Sep;5(3):193-206. doi: 10.1007/s40801-018-0141-1.
Safety data of many drugs used during pregnancy remain scarce. This is especially true in developing countries characterised by the absence of a robust pharmacovigilance system, high prevalence of different tropical diseases affecting patients and potential for drug-drug interactions. This study aimed to assess the safety profile of drugs used in women at high risk of malaria during pregnancy and delivery in Burkina Faso's health facilities. It also aimed to assess factors associated with the use of potentially risky drugs over the entire course of pregnancy.
We enrolled pregnant women from their first antenatal care visit and followed them up until delivery, and collected data on drug use. Based on United States Food and Drug Administration (FDA) or Australian Therapeutic Goods Administration (TGA) drug risk classification, drugs were classified into three groups: 'probably safe', 'potentially risky' or 'unclassified'. A modified classification was built to take into account national malaria policy treatment guidelines and World Health Organization Malaria Treatment Guidelines recommending malaria chemoprophylaxis during pregnancy.
Out of 2371 pregnant women enrolled, 56.7% used at least one medication during the entire course of the pregnancy (excluding sulphadoxine-pyrimethamine and iron-folic acid). A total of 101 different types of medications were used by study participants and 36.6, 49.5 and 13.9% were, respectively, classified as 'probably safe', 'potentially risky' and 'unclassified'. Antimalarials and antibiotics were the most frequently used drugs. Around 39% of women used a least one medication classified as potentially risky. However, this proportion dropped to 26% with the modified classification. Living in urban areas and attending the first antenatal care within their first trimester of pregnancy (longer health surveillance) were associated with using 'potentially risky' medications.
This study provides rare and valuable information on the current use of drugs among pregnant women in Burkina Faso. Many pregnant women used medications classified as potentially risky. Our findings suggest the need for rational drug prescription and community education to reduce hazardous drug exposure during pregnancy.
许多孕期使用药物的安全性数据仍然匮乏。在缺乏健全药物警戒系统、影响患者的各种热带疾病高发且存在药物相互作用可能性的发展中国家，情况尤其如此。本研究旨在评估布基纳法索医疗机构中孕期和分娩时处于疟疾高风险的女性所使用药物的安全性概况。它还旨在评估整个孕期使用潜在风险药物的相关因素。
我们从孕妇首次产前检查开始招募，并对她们进行随访直至分娩，收集用药数据。根据美国食品药品监督管理局（FDA）或澳大利亚治疗用品管理局（TGA）的药物风险分类，药物被分为三组：“可能安全”、“潜在风险”或“未分类”。构建了一个改良分类，以考虑国家疟疾政策治疗指南以及世界卫生组织疟疾治疗指南中关于孕期疟疾化学预防的建议。
在纳入的2371名孕妇中，56.7%在整个孕期（不包括周效磺胺 - 乙胺嘧啶和铁 - 叶酸）至少使用了一种药物。研究参与者共使用了101种不同类型的药物，分别有36.6%、49.5%和13.9%被分类为“可能安全”、“潜在风险”和“未分类”。抗疟药和抗生素是使用最频繁的药物。约39%的女性至少使用了一种被分类为潜在风险的药物。然而，采用改良分类后，这一比例降至26%。居住在城市地区以及在孕早期进行首次产前检查（更长的健康监测期）与使用“潜在风险”药物有关。
本研究提供了布基纳法索孕妇当前用药情况的罕见且有价值的信息。许多孕妇使用了被分类为潜在风险的药物。我们的研究结果表明需要合理用药处方和社区教育，以减少孕期有害药物暴露。
